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Darvocet/Darvon Recall The manufacturer of the pain medication Darvon and Darvocet announced on November 19, 2010 that it will recall the popular painkillers due to serious and potentially fatal heart rhythm abnormalities associated with the drug resuting in arrthymia, heart attack and cardiac arrest. Xanodyne Pharmaceutical Incorporated, of Newport Kentucky, agreed to the ban at the request of the Food and Drug Administration, which also requested a ban on the generic version, known as Propoxyphene. This decision is similar to the regulatory action taken in Britain and the European Union, which ban sales of the drugs from the market more than a year ago. Darvon/Darvocet was first approved by the FDA in 1957, but has long been plagued by safety concerns. In January 2009, an FDA advisoory committee voted to ban the drug, but the FDA rejected the recommendation, requiring additional study of the drug. The recent study showed an increase risk for heart arrhythmias, even in otherwise healthy patients. The FDA estimataes 10 million patients received the drug in 2009. |
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